Solution for injection.

For treatment of lameness in
horses due to traumatic or degenerative aseptic joint disease and
acute superficial digital flexor tendonitis.

4.3 Contraindications

Do not use in animals with
known hypersensitivity to the active ingredient.

Do not use in cases of advanced
renal or hepatic disease.

Do not use in pregnant
animals.

4.4 Special warnings for each target species

None.

Special precautions for use

i. Special precautions for use
in animals

For intramuscular
administration only.

If signs or symptoms of
hypersensitivity occur, the treatment must be discontinued.

ii. Special
precautions to be taken by the person administering the medicinal
product to animals

Care should be taken to avoid
accidental self-injection.

In the case of accidental eye
or skin contact, wash the affected area thoroughly with copious
amounts of water. If irritation persists, seek medical
attention.

4.6 Adverse reactions (frequency
and seriousness)

None known.

4.7 Use during pregnancy,
lactation or lay

Adequan should not be used in
pregnant animals.

4.8 Interaction with other
medicinal products and other forms of interaction

Adequan may potentiate the
action of anticoagulant preparations.

4.9 Amount to be administered
and administration route

The contents of a 5 ml vial are
injected by deep intra-muscular injection every four days for a
total of seven injections.

This product does not contain
an antimicrobial preservative. Any solution remaining in the vial
after withdrawal of the required dose should be discarded.

4.10 Overdose (symptoms, emergency procedures,
antidotes)

In the case of overdosage,
blood coagulation time, as measured by activated partial
thromboplastin time, may be prolonged for a few hours after the
injection.

4.11 Withdrawal period

Meat and offal - Zero days

5. PHARMACOLOGICAL
PROPERTIES

ATC
Vetcode:QM01AX12

Glucosaminoglycan polysulfate

5.1 Pharmacodynamic
properties

The active ingredient is a
semisynthetic substance, similar to the physiological
mucopolysaccharides which are the basic component of cartilage. In
healthy joints, the synthesis and degradation of cartilage is in
equilibrium. In traumatic and degenerative joint disease, the
natural equilibrium between synthesis and degradation of the
cartilage is disturbed. This results in an increased degradation
which further results in a loss of glycosaminoglycans.

Variousin-vitrostudies and animal models have been employed to investigate
the anti-osteoarthritis activities of PSGAG.

The finding, that the
development and progression of degenerative joint diseases were
inhibited in all species and models tested, indicates that PSGAG
will also therapeutically influence degenerative or traumatic joint
diseases in horses.

5.2. Pharmacokinetic
particulars

Pharmacokinetic studies were
carried out in animals (rats and rabbits) and humans with
radioactively labelled PSGAG. After intramuscular administration to
humans, maximum plasma levels were reached within 30 minutes and
decreased by half after 3 to 5 hours.

The intramuscular administration
of 125 mg/ml PSGAG to humans indicates that PSGAG has an affinity
to cartilage. The levels in cartilage were higher than the values
measured in serum or the synovia. While the serum levels decreased
within 12 hours, the concentration in cartilage increased up to 24
hours and remained on a plateau at about 5g/g up to 48 hours. Organ
distribution and metabolism were investigated in rats and rabbits.
In the tissues (kidney, liver, spleen, bone marrow), unchanged
PSGAG was detected together with partially depolymerized and
desulphated metabolites, which were also eliminated in the urine.
Less than 1 per cent of PSGAG was eliminated in the
faeces.

6. PHARMACEUTICAL
PARTICULARS

List of excipients

Sodium hydroxide

Sodium chloride

Hydrochloric acid (dilute)

Water for injection

6.2 Incompatibilities

In the absence of compatibility
studies, this veterinary medicinal product must not be mixed with
other veterinary medicinal products.

6.3 Shelf life

Shelf life of the veterinary
medicinal product as packaged for sale: 3 years.